Muromonab

Information about Muromonab

Muromonab-CD3 is a mouse monoclonal antibody to CD3, often referred to as OKT3, which is used to treat acute cellular rejection after solid organ transplantation.

Liver safety of Muromonab

Muromonab has been linked to mild and transient serum enzyme elevations during therapy, but has not been linked to cases of clinically apparent liver injury. Muromonab is a potent immunosuppressive agent and may result in reactivation of hepatitis B in susceptible patients.

Mechanism of action of Muromonab

Muromonab (mue” roe moe’ nab) is a mouse monoclonal immunoglobulin G2 antibody to CD3, a cell surface receptor found on T cells. Engagement of the receptor leads to T cell activation, but without secondary signals the binding results in blockage and T cell apoptosis. Infusions of muromonab lead to depletion of T cells and decrease in T cell activity which is the major cause of acute cellular rejection.

FDA approval information for Muromonab

Muromonab was approved for use in treating acute rejection after renal transplantation in 1997 and its indications were later broadened to include rejection after heart and liver transplantation.

History of Muromonab

Muromonab was the first monoclonal antibody approved for use in humans and is still used commonly to treat acute rejection. Muromonab is used off label to prevent cellular rejection, given as induction therapy before and/or early after transplantation. The name “muromonab” represents a shortened form of “murine monoclonal antibody” and was assigned before the official WHO nomenclature for monoclonal antibodies was introduced. Muromonab-CD3 is available in liquid solution in 5 mL ampules of 5 mg under the brand name Orthoclone OKT3.

Dosage and administration for Muromonab

The usual regimen in adults is 5 mg intravenously each day for 10 to 14 days. The pediatric dose (<30 kg) is 2.5 mg daily.

Side effects of Muromonab

Adverse events are common during muromonab therapy, but many are due to the underlying condition and other complications of organ transplantation. Muromonab is a mouse monoclonal antibody and hypersensitivity reactions and development of inactivating antibodies occur not infrequently. Furthermore, the initial engagement of CD3 receptors can result in a transient, acute release of proinflammatory cytokines (cytokine release syndrome) with symptoms of high fever, weakness, dyspnea, nausea, chest pain and diarrhea arising within the first two days of starting therapy. Less common, but potentially severe adverse reactions after muromonab therapy include bacterial and opportunistic infections, reactivation of viral infections (EBV, HSV, CMV, HBV, RSV, among others), acute thromboses, and malignancies, particularly EBV-associated lymphoproliferative disorders. The following drugs used to prevent transplant rejection.

Immunosuppressants

• Cyclosporine
• Everolimus
• Mycophenolate
• Sirolimus
• Tacrolimus

Monoclonal Antibodies

• Alemtuzumab
• Basiliximab
• Daclizumab
• Muromonab

Antithymocyte Globulin

• Dailymed label info on Muromonab
• FDA Muromonab

Muromonab Resources
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